MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 LFIT V40 HEAD; IMPLANT

Catalog Number 6260-9-232

Device Problem Break (1069)

Patient Problem Joint Dislocation (2374)

Event Date 11/26/2014

Event Type  Injury  

Event Description

Patient presented with hip pain.X-rays showed a dislocation due to a broken constrained liner.Patient had a previous surgery approximately 10 years prior at which time a proximal femoral replacement gmrs was implanted in conjunction with a zimmer cup and constrained liner.Dr (b)(6) decided to explant the zimmer cup and implant a stryker 64mm tritanium cup and 28mm 0 degree g constrained liner along with a lfit +4 28mm head.

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown 32mm v40 +4mm lfit head.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Hosp does not release explants.

Manufacturer Narrative

An event regarding dislocation involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection was not performed as the device was not returned due to hospital policy.Medical records received and evaluation: insufficient information was received for review with a clinical consultant.Device history review was not performed as the lot id was not provided.Complaint history review was not performed as the lot id was not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, x-rays, patient history and follow-up notes are needed to investigate this event further.

Event Description

Patient presented with hip pain.X-rays showed a dislocation due to a broken constrained liner.Patient had a previous surgery approximately 10 years prior at which time a proximal femoral replacement gmrs was implanted in conjunction with a zimmer cup and constrained liner.Dr (b)(6) decided to explant the zimmer cup and implant a stryker 64mm tritanium cup and 28mm 0 degree g constrained liner along with a lfit +4 28mm head.

• Brand Name: 32MM +4 LFIT V40 HEAD
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ 07430 NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4354025
• MDR Text Key: 5173270
• Report Number: 0002249697-2014-04849
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6260-9-232
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2015
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR